SMR, RTU enter license agreement for RESCULA eye drops

Mar 23 2011

Sucampo Pharmaceuticals, Inc. ("Sucampo") (SPI), (NASDAQ: SCMP) today announced that its wholly owned subsidiary, Sucampo Manufacturing & Research AG (SMR), and R-Tech Ueno, Ltd. (RTU) (JASDAQ code: 4573), a pharmaceutical company founded in Japan in 1989, have entered into a license agreement for RESCULA^® (unoprostone isopropyl) eye drops, expanding Sucampo's rights beyond its previously agreed territory of the United States and Canada to all countries in Europe and the rest of the world except Japan, Korea, Taiwan and the People's Republic of China (the "SMR Territories"). This alliance insures state of the art global development and commercialization between the Sucampo family of companies and R-Tech Ueno for all current and potential indications.

Unoprostone isopropyl is currently approved in the U.S. for the lowering of intraocular pressure (IOP) in primary open-angle Glaucoma and Ocular Hypertension patients intolerant of or insufficiently responsive to other IOP-lowering medications. In Europe, unoprostone isopropyl is approved for the lowering of IOP in patients with Open-Angle Glaucoma or Ocular Hypertension. It is approved in the United Kingdom and France for the lowering of IOP in open-angle Glaucoma and Ocular Hypertension patients and in Japan for the treatment of Glaucoma and Ocular Hypertension. In addition, Sucampo management is studying unoprostone isopropyl for the potential treatment of Retinitis Pigmentosa, Dry Age-related Macular Degeneration (dry AMD) and other retinal indications. Sucampo is conducting a series of pre-clinical and clinical studies that may lead to the initiation of a phase 2 clinical trial for dry AMD later this year.

Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman and Chief Executive Officer of Sucampo Pharmaceuticals, said, "We are very excited about this agreement, as we believe that unoprostone isopropyl has significant potential in several markets. It is already approved in the United States, Japan and some European countries as a treatment for Glaucoma and Ocular Hypertension. We will move forward to reactivate the licenses in Switzerland and the European Union for Glaucoma and Ocular Hypertension as we continue our efforts to achieve a scientifically accurate and updated supplemental new drug application label in the U.S. At the same time, we will pursue additional indications such as dry AMD and Retinitis Pigmentosa. Unoprostone isopropyl has shown new potential in Retinitis Pigmentosa patients in an RTU-sponsored trial that showed a dose-dependent improvement in retinal sensitivity after only six months of treatment. If unoprostone isopropyl is successfully developed for these additional indications, it will increase our ability to fulfill our mission of offering new therapeutic options to ophthalmology patients."

Yukihiko Mashima, M.D., Ph.D., President and Chief Executive Officer of R-Tech Ueno Ltd., said, "We are very pleased to sign this agreement with Sucampo with its thorough knowledge of unoprostone isopropyl, as it will further enhance unoprostone isopropyl's value beyond Glaucoma and Ocular Hypertension. R-Tech is focused on the development of new drugs for unmet medical needs, and we believe that unoprostone isopropyl will contribute to the quality of life of a wider population of ophthalmology patients."